Job Description

The Director serves as the head of the Quality Management and Regulatory Affairs team and leads, manages, and supports all medical device Quality System and Regulatory activities. Serves as Management Representative and Person Responsible for Regulatory Compliance (PRRC).

Responsibilities:

• Manage the site Quality Management System, including management reviews, complaint handling, CAPA system, document control, change control, calibration, validation maintenance, internal auditing, training, and manufacturing support.
• Ensures compliance with DemeTECH Quality Policies, cGMP, ISO, MDD/MDR quality systems requirements.
• Review and approve all quality system documentation, including but not limited to: Standard Operating Procedures (SOPs), Work Instructions (WIs), Forms, Validation Protocols and Reports, Device Master Records, Product Labeling, and Specifications.
• Review and approve all Qualification and Validation Protocols and Reports.
• Coordinate ISO certification and maintenance.
• Guiding the management team to ensure that operations are within the required regulatory guidelines for products from a final product acceptance and compliance perspective.
• Maintain quality system performance metrics.
• Ensure conformity of the device to the manufacturer's QMS prior to release.
• Ensure technical documentation and EU Declaration of Conformity (DoC) are current.
• Ensure effective transfers of new products into production that meet all Quality requirements for the classification.
• Conduct the Management Review, providing reports of tracking of Quality Metrics to Top Management.
• Authorize the rework of non-conforming product and conducts the material review and disposition at the completion of the rework. Evaluates whether or not product does or does not meet all specifications and requirements prior to final release.
• Oversee the environmental monitoring program.
• Evaluate returned product and dispositions product.
• Notify Management of any Product Quality issues and major deviations.
• Conducts product recalls and/or vigilance reporting
• Oversee/perform internal audits and audits of external suppliers and service providers.
• Host external auditors, customers and regulatory inspections including FDA and foreign regulatory agencies.
• Oversee and maintain Supplier Qualification Program.
• Manage communication with all economic operators.

Qualifications and Educational Requirements

Education: BS Chemistry, Biology, Biomedical Engineering, or similar scientific/technical field. Working knowledge of cGMP, ISO 13485, and EU Medical Device Directive (MDD)/Regulations (MDR). Fluent in English. Spanish is a plus.

Communication skills: Position involves contacts with individuals inside and/or outside the Organization where the nature of the information provided usually follows an established pattern. Excellent verbal and written communication and skills.

Technical Proficiencies: Organizational Skills, Excel, Minitab, Presentation Skills, Project Management, Results Driven, Mathematical Skills, Technical Capacity, Thoroughness, Time Management.

Judgment and Decision Making: Collect, interpret, and/or analyze complex data and information. Demonstrated proficiency in supervising and motivating subordinates. Proven ability to handle multiple projects and meet deadlines.

Experience: Minimum of 5-10 years regulatory/quality assurance or quality engineering supervisory experience in an FDA registered facility for medical device manufacturing. Requires thorough knowledge of FDA Quality System Regulation (QSR) experience for medical device manufacturing. Knowledge of the Medical Device regulations and their appropriate application is needed to assure compliance with regards to manufacturing.

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